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Magnetic Resonance Imaging (MRI) in Predicting Response to Sunitinib Malate in Patients With Locally Advanced or Metastatic Kidney Cancer

2014-08-27 03:17:31 | BioPortfolio

Summary

Rationale: Diagnostic procedures, such as MRI, may help doctors predict a patient's response to treatment and help plan the best treatment.

Purpose: This clinical trial is studying MRI in predicting response to sunitinib malate in patients with locally advanced or metastatic kidney cancer.

Description

Primary Objectives:

I. To correlate tumor vascular permeability by DCE-MRI with clinical outcome for patients treated with sunitinib (PFS).

II. To correlate genetic and histologic characteristics of the primary tumor with vascular permeability by DCE-MRI.

Secondary Objectives:

I. To correlate genetic and histologic characteristics of the primary tumor with clinical outcome for patients treated with sunitinib.

II. Samples will be collected for potential future exploratory analyses of pharmacokinetic and pharmacogenomic parameters.

Outline: Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity.

Patients undergo dynamic contrast-enhanced MRI at baseline and after the first 4 weeks of sunitinib malate.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Renal Cell Carcinoma

Intervention

mutation analysis, pharmacological study, dynamic contrast-enhanced magnetic resonance imaging, sunitinib malate, immunohistochemistry staining method, laboratory biomarker analysis

Location

Abramson Cancer Center of The University of Pennsylvania
Philadelphia
Pennsylvania
United States
19104

Status

Recruiting

Source

Abramson Cancer Center of the University of Pennsylvania

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:31-0400

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